UMIN-CTR Clinical Trial

Basic information
Public title	Questionnaire survey about information and support for patients with lung cancer, mesothelioma or thymic tumor
Acronym	Questionnaire survey about information and support for thoracic cancer patients
Scientific Title	Questionnaire survey about information and support for patients with lung cancer, mesothelioma or thymic tumor
Scientific Title:Acronym	Questionnaire survey about information and support for thoracic cancer patients
Region	Japan

Condition
Condition	lung cancer, mesothelioma and thymic tumor
Classification by specialty	Pneumology Hematology and clinical oncology Surgery in general Chest surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the degree of satisfaction with medical information obtained by patients. We conduct a questionnaire survey of patients with lung cancer, mesothelioma, and thymic tumor. The questionnaire contains questions from researchers, EORTC QLQ C30 and INFO25.
Basic objectives2	Others
Basic objectives -Others	The purpose is to improve the content and quality of medical information to be provided.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Compare the degree of satisfaction with the medical information obtained between the purchase group and the non-purchase group of [Lung cancer guidebook for patients].
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients diagnosed with lung cancer, malignant pleural mesothelioma, or thymic tumor (histopathological diagnosis is not essential) 2) Patients consent to this study registration
Key exclusion criteria	Not applicable.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Sawa Middle name Last name Toshiyuki
Organization	Gifu municipal Hospital
Division name	Cancer center
Zip code	500-8513
Address	7-1, Kashima-cho,Gifu city, Gifu
TEL	(058)251-1101
Email	sawatoshiyuki@yahoo.co.jp

Public contact
Name of contact person	1st name Takayuki Middle name Last name Takahama
Organization	Kindai University Nara Hospital
Division name	Department of medical oncology
Zip code	6300293
Address	1248-1, Otoda, Ikoma city, Nara
TEL	0743-77-0880
Homepage URL
Email	takahama_t@med.kindai.ac.jp

Sponsor
Institute	The Japan lung cancer society
Institute
Department

Funding Source
Organization	The Japan lung cancer society
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kindai University Nara Hospital
Address	1248-1, Otoda, Ikoma city, Nara
Tel	0743-77-0880
Email	n-rinri@med.kindai.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	332
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2020 Year 06 Month 29 Day
Date of IRB	2020 Year 06 Month 30 Day
Anticipated trial start date	2020 Year 07 Month 03 Day
Last follow-up date	2022 Year 07 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Request QOL survey and input from researcher's questionnaire.

Management information
Registered date	2020 Year 07 Month 02 Day
Last modified on	2021 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046798